title: Incidence and predictors of immune reconstitution inflammatory syndrome in a rural area of Mozambique.
abstract: BACKGROUND
  There is limited data on the epidemiology of Immune Reconstitution Inflammatory Syndrome (IRIS) in rural sub-Saharan Africa. A prospective observational cohort study was conducted to assess the incidence, clinical characteristics, outcome and predictors of IRIS in rural Mozambique.
  
  
  METHODS
  One hundred and thirty-six consecutive antiretroviral treatment (ART)-naïve HIV-1-infected patients initiating ART at the Manhiça district hospital were prospectively followed for development of IRIS over 16 months. Survival analysis by Cox regression was performed to identify pre-ART predictors of IRIS development.
  
  
  RESULTS
  Thirty-six patients developed IRIS [26.5%, incidence rate 3.1 cases/100 persons-month of ART (95% CI 2.2-4.3)]. Median time to IRIS onset was 62 days from ART initiation (IQR 35.5-93.5). Twenty-five cases (69.4%) were "unmasking", 10 (27.8%) were "paradoxical", and 1 (2.8%) developed a paradoxical worsening followed by the unmasking of another condition. Systemic OI (OI-IRIS) accounted for 47% (17/36) of IRIS cases, predominantly of KS (8 cases) and TB (6 cases) IRIS. Mucocutaneous IRIS manifestations (MC-IRIS) accounted for 53% (19/36) of IRIS events, mostly tinea (9 cases) and herpes simplex infection (3 cases). Multivariate analysis identified two independent predictors of IRIS development: pre-ART CD4 count <50 cells/µl (HR 2.3, 95% CI 1.19-4.44, p = 0.01) and body mass index (BMI) <18.5 (HR 2.15, 95% CI 1.07-4.3, p = 0.03). The pre-cART proportion of activated T-cells, as well as the immunologic and virologic response to ART were not associated with IRIS development. All patients continued on ART, 7 (19.4%) required hospitalization and there were 3 deaths (8.3%) attributable to IRIS.
  
  
  CONCLUSIONS
  IRIS is common in patients initiating ART in rural Mozambique. Pre-ART CD4 counts and BMI can easily be assessed at ART initiation in rural sub-Saharan Africa to identify patients at high risk of IRIS, for whom close supervision is warranted.
authors.affiliation: Centro de Investigação em Saúde de Manhiça, Manhiça, Maputo, Mozambique. emili.letang@cresib.cat
authors.forename: Emilio
authors.initials: E
authors.lastname: Letang
authors.forename: José M
authors.initials: JM
authors.lastname: Miró
authors.forename: Tacilta
authors.initials: T
authors.lastname: Nhampossa
authors.forename: Edgar
authors.initials: E
authors.lastname: Ayala
authors.forename: Joaquim
authors.initials: J
authors.lastname: Gascon
authors.forename: Clara
authors.initials: C
authors.lastname: Menéndez
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Alonso
authors.forename: Denise
authors.initials: D
authors.lastname: Naniche
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D005260:Female; D006801:Humans; D054019:Immune Reconstitution Inflammatory Syndrome / Q000175:diagnosis* / Q000453:epidemiology* / Q000209:etiology; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009073:Mozambique / Q000453:epidemiology; D011379:Prognosis; D012307:Risk Factors; D012424:Rural Population / Q000706:statistics & numerical data*; D055815:Young Adult